COVID-19: ANMAT approved emergency use of Johnson & Johnson vaccine

The National Administration of Drugs, Food and Medical Technology (ANMAT) authorized the emergency use of Janssen’s vaccine against the COVID-19 disease caused by the coronavirus, an inoculation that is not yet available in the country.

The resolution specifies that Janssen Pharmaceuticals Single Dose Vaccine Gets ‘Emergency Registration’, also known as Johnson & Johnson.

The provision 7502 of October 1 of the national drug control body states: “Authorize Janssen Cilag Farmaceutica SA in the context of the Covid 19 pandemic, the conditional registration for the purposes of its use in the Register of Medicinal Specialties (REM) and of the National Administration of Medicines, Food and Medical Technology of the medicinal specialty of the trade name Covid-19 Vaccine Janssen and of the name generic Vacuna Contra Covid-19, which, according to the request, will be marketed in the Argentine Republic by Janssen Cilag Farmaceutica SA in accordance with the characteristic identification data of the product included in the registration certificate ”.

Article 2 specifies that “By virtue of being a conditional authorization, the validity of the Certificate will be 1 (ONE) year from the date of this Provision.”

The document, which bears the signature of Manuel Limeres of ANMAT, specifies that the company must “Submit periodic safety reports every 6 months after the effective marketing of the product to the INAME (National Institute of Medicines) ”.

It also specifies that “any modification of the safety or efficacy profile of the product must be confirmed in the amendment corresponding to the package insert”. And that in the event of non-compliance with the established obligations, the ANMAT may “suspend the marketing of the product approved by this provision, when public health considerations justify it”.

High efficiency

The Covid-19 vaccine developed by the Johnson & Johnson company was urgently authorized on February 27 in the United States. In this country, it has been shown to be 72% effective in protecting the person against the coronavirus. It is one of the few that only requires one dose. As with other inoculants, the vaccine continued to be studied in the real world after clearings in Europe, Canada and other countries.

Now the results of a Johnson & Johnson vaccine study conducted in South Africa have been released, indicating a reduction in the risk of contracting the disease by about half.

These are the results of a trial involving nearly half a million health workers in South Africa. The “Sisonke” study was part of a collaboration between the Department of Health, the South African Council for Medical Research, the Desmond Tutu Health Foundation, the Center for AIDS Research Program in South Africa and the Janssen / Johnson & Johnson. . The single-dose vaccine was used to immunize 479,768 healthcare workers between mid-February and mid-May.

“The vast majority of infections that have occurred have been mild,” said scientist Glenda Gray, co-director of the study. Data from the trials have not yet been published in a peer-reviewed journal. The inoculant had previously been shown to be effective in reducing the risk of developing serious illness. Like most of the first generation COVID-19 vaccines that were developed last year, The Johnson & Johnson inoculant has been designed and tested for its ability to prevent hospitalizations and death from coronavirus infection. However, some people who are already immune can be infected, and this highlighted the challenge that health authorities face today in achieving control of the pandemic, at a time when worrying variants of the virus, like Delta, have germinated. germs in different countries. .

Johnson & Johnson’s vaccine offered 91% to 96.2% protection against the risk of death, while providing 67% protection against hospitalization when the beta variant of the coronavirus was dominant and about 71% protection from hospitalization when the Delta variant dominated.

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